Going Dutch

How pharma regulation could change after the European Medicines Agency moves from London to Amsterdam

When Amsterdam was pulled out of the hat in November 2017 as the new location for the European Medicines Agency (EMA), there was general relief at the EU regulatory body. “Amsterdam ticks many of our boxes,” said EMA executive director Guido Rasi, who expects much of the 900 staff to move with the agency when it quits London in preparation for the UK’s exit from the EU in March 2019. Yet while the EMA’s location is settled, other issues are far from clear. Among them are exactly how the UK will work with the EMA after Brexit, and whether the EMA’s own priorities will change once the UK’s influence wanes.

The general hope in the pharma industry is that little will change after Brexit. After all, the EMA is not the only route to market for products at the moment: pharma companies can (and often do) apply to it as the central authorising body for the EU, but there are only a few disease areas where they are obliged to do so. Many new EU products are actually approved by national regulators, including the UK’s MHRA, and then sold across multiple countries under a system of mutual recognition. Mutual recognition is possible because all the regulators operate under EMA rules and oversight.

MHRA rules will continue to be similar to EMA ones even after Brexit, thanks to the Brexit Bill that will transpose all EU law into UK law on exit. Even so, according to the EMA guidance published in November 2017, everything will change in 2019 unless we get a deal. Any existing marketing approvals and decisions will stand, because they were agreed under EU rules, but in future companies will have to apply to both the MRHA and the EMA separately. They will also have to have separate ‘qualified persons’ in both the UK and EU to hold marketing rights and to oversee batch separate inspections.

However, if the UK strikes a deal to stay in the European Economic Area (EEA), if only for medicines, then this duplication would be kept to a minimum. Replicating marketing approval would be a formality: Norway and other EEA countries generally grant it within 30 days of EMA. The MHRA could stay as an observer at the EMA, following its rules, and may even stay closely aligned enough to carry on picking up some of the EMA workload. The UK could also continue to be a recognised location for batch testing and qualified persons, and its research would also count towards EU clinical trial data and other evidence.

How the Swiss roll

A Swiss-type deal on mutual recognition would be similar in many ways, allowing actions by the UK regulator to count towards EU authorisation. However, the process would be slightly more arduous in terms of paperwork unless the UK slavishly follows EMA rules. Switzerland generally gets new drugs about six months later than the EU. If the UK leaves without any deal at all, then nearly all paperwork will have to be done twice – and the UK will have less incentive to stay aligned with the EMA in future, particularly if the European rules are seen as preventing drugs getting to market.

In short, it will be a trade-off between the UK’s freedom to export to the EU and its freedom to shape its own medicines market. Despite the potential barriers to EU trade, there could be some advantages to moving away from EMA rules. The MHRA could, for example, introduce an expedited authorisation procedure to allow particular types of innovative drugs earlier access to the UK market. Or it could loosen the rules on clinical trial data, which are becoming more restrictive in the EU, in order to lower research costs. However, any moves the UK makes in this direction would affect its ability to agree common ground with the EU, putting a strain on any mutual recognition deal.

Which brings us to the other question hovering over EMA’s move to Amsterdam: will it change the nature of the agency and the future direction of its rules? With its staffing currently heavily biased towards UK nationals, and heavy use of UK-based experts, the UK’s influence over EMA is strong. Indeed that is why so many Japanese and other non-EU pharma companies like to be based in the UK, so that they can benefit from EMA’s London base.

Many of the staff may move with the agency, but eventually they will leave and other EU nationals will take their place. Each will bring with them a different background, including a different attitude to the trade-offs between safety and speed in getting drugs to market or between the need to cut red tape and the need for regulation. They will also have a different attitude towards scientific evidence, and how rigorous it should be. And if those attitudes are reflected in new EMA rules that the UK can no longer be comfortable with, any deal we strike now may not last – particularly if the UK sees greater trading opportunities beyond Europe anyway.